Ischemic StrokeTTT-AIS CHINANCT06078995
Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China
An observational study of Ischemic Stroke, run by Huashan Hospital at 1 site in China.
Trial summary
The objective of the study is to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients within 4.5 hours of symptom onset in a real-world clinical setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Tenecteplase and Alteplase
- Type of treatment
- Injection or infusion
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: acute ischemic stroke patients treated with rhTNK-tPA or rt-PA in China.
Who may be able to join
- all acute ischaemic stroke patients who met eligibility for thrombolysis with intravenous alteplase or TNK and presenting within 4·5 hours of symptom onset.
Who cannot join
- variables with a missing rate > 40%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world, Multicenter, Retrospective, Controlled Study
The objective of the study is to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients within 4.5 hours of symptom onset in a real-world clinical setting.
Read the detailed description
Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has the logistic advantage of a single bolus infusion over recombinant tissue plasminogen activator (rt-PA) which needs a 1-hour infusion. The non-inferiority of rhTNK-tPA compared to rt-PA was proved by two recent randomized controlled clinical trials but the evidence is lacking regarding the real-world effectiveness and safety of rhTNK-tPA.
This is a multi-center, observational, retrospective study that enrolled acute ischemic stroke patients treated with rhTNK-tPA thrombolysis in China.
- Conditions
- Ischemic Stroke
- Being tested
- Tenecteplase, Alteplase
- Keywords
- intravenous thrombolysis, Tenecteplase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenecteplaseDrug
Also called rhTNK-tPA
Thrombolysis wtih rhTNK-tPA
AlteplaseDrug
Also called rt-PA
Thrombolysis wtih rt-PA
| Study group | Role | What they receive |
|---|---|---|
| Tenecteplase | acute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase Receives: Drug: Tenecteplase | |
| alteplase | acute ischemic stroke patients who receive intravenous thrombolysis with alteplase Receives: Drug: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with symptomatic intracranial hemorrhage within 36 hours
Clinical deterioration or neurological decline causing an increase in NIHSS score of ≥4 points due to intracranial hemorrhage confirmed by brain imaging
Measured: 36 hours
Secondary outcomes (8)
90 days mRS 0-1
modified Rankin Scale score measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.
Measured: at 90±7 days
90 days mRS shift
a shift analysis of the distribution of modified Rankin Scale score which measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.
Measured: at 90±7 days
discharge mRS
modified Rankin Scale score measures degree of disability/dependence after a stroke. Patients are graded on the scale of 0-6, with higher scores indicating worse functional outcome. 0 means no symptoms, 6 means death.
Measured: at discharge (up to 30 days)
24 hours NIHSS score
The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Scores range from 0 to 42, with higher scores indicating greater severity.
Measured: at 24 hours after receiving thrombolysis
discharge NIHSS score
The NIH Stroke Scale/Score (NIHSS) quantifies stroke severity based on weighted evaluation findings. Scores range from 0 to 42, with higher scores indicating greater severity.
Measured: at discharge (up to 30 days)
Rate of patients with any systematic bleeding
Rate of patients with any systematic bleeding requiring blood infusion during hospital stay reflecting short term safety outcome
Measured: during hospital stay (up to 30 days)
Rate of patients with 90 days mortality
Rate of patients with all-cause mortality within 90 days reflecting safety outcome
Measured: at 90±7 days
Rate of patients with any intracranial hemorrhage
Rate of patients with any intracranial hemorrhage without significant neurological deterioration on the brain imaging reflecting short term safety outcome
Measured: during hospital stay (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start2 Apr 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Keshiketeng Banner Traditional Chinese Medicine Mongolian Medicine Hospitalorem Ipsum, Nanyang Nanshi Hospital, First Affiliated Hospital of Ningbo University, Jilin Liuhe Hospital, Shenyang Fifth People's hospital, Shanghai East Hospital, Shanghai 10th People's Hospital, Fudan University, Shanghai Pudong Gongli hospital, Shanghai Neuromedical Center, Shanghai Fourth People's Hospital, Shanghai Pudong People's Hospital, Shanghai Putuo District Center Hospital, Shenyang Fushun general hospital of mining bureau, Yantai Affliated Hosiptal of Binzhou Medical University, Shanghai Ninth People's Hospital Huangpu Branch, Shanghai Deji Hospital, Ruijin Hospital Luwan Branch
- Responsible party
- Principal investigator, Qiang Dong, Huashan Hospital
- Investigators
- Qiang Dong, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078995
- Sponsor's protocol ID
- 20230726
- Acronym
- TTT-AIS CHINA
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world, Multicenter, Retrospective, Controlled Study
- ClinicalTrials.gov ID
- NCT06078995
- Acronym / sponsor ID
- TTT-AIS CHINA / 20230726
- Conditions
- Ischemic Stroke
- Keywords
- intravenous thrombolysis, Tenecteplase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Keshiketeng Banner Traditional Chinese Medicine Mongolian Medicine Hospitalorem Ipsum, Nanyang Nanshi Hospital, First Affiliated Hospital of Ningbo University, Jilin Liuhe Hospital, Shenyang Fifth People's hospital, Shanghai East Hospital, Shanghai 10th People's Hospital, Fudan University, Shanghai Pudong Gongli hospital, Shanghai Neuromedical Center, Shanghai Fourth People's Hospital, Shanghai Pudong People's Hospital, Shanghai Putuo District Center Hospital, Shenyang Fushun general hospital of mining bureau, Yantai Affliated Hosiptal of Binzhou Medical University, Shanghai Ninth People's Hospital Huangpu Branch, Shanghai Deji Hospital, Ruijin Hospital Luwan Branch
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients within 4.5 hours of symptom onset in a real-world clinical setting.
Detailed description
Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has the logistic advantage of a single bolus infusion over recombinant tissue plasminogen activator (rt-PA) which needs a 1-hour infusion. The non-inferiority of rhTNK-tPA compared to rt-PA was proved by two recent randomized controlled clinical trials but the evidence is lacking regarding the real-world effectiveness and safety of rhTNK-tPA.
This is a multi-center, observational, retrospective study that enrolled acute ischemic stroke patients treated with rhTNK-tPA thrombolysis in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenecteplase | – | Drug: Tenecteplaseacute ischemic stroke patients who receive intravenous thrombolysis with tenecteplase |
| alteplase | – | Drug: Alteplaseacute ischemic stroke patients who receive intravenous thrombolysis with alteplase |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- acute ischemic stroke patients treated with rhTNK-tPA or rt-PA in China.
Key inclusion criteria (1 listed)
- all acute ischaemic stroke patients who met eligibility for thrombolysis with intravenous alteplase or TNK and presenting within 4·5 hours of symptom onset.
Key exclusion criteria (1 listed)
- variables with a missing rate > 40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenecteplaseAlso: rhTNK-tPAThrombolysis wtih rhTNK-tPA | Drug | Tenecteplase |
| AlteplaseAlso: rt-PAThrombolysis wtih rt-PA | Drug | alteplase |
Primary outcome
Rate of patients with symptomatic intracranial hemorrhage within 36 hours
Time frame: 36 hours
Clinical deterioration or neurological decline causing an increase in NIHSS score of ≥4 points due to intracranial hemorrhage confirmed by brain imaging
8 secondary outcomes
90 days mRS 0-1
Time frame: at 90±7 days
90 days mRS shift
Time frame: at 90±7 days
discharge mRS
Time frame: at discharge (up to 30 days)
24 hours NIHSS score
Time frame: at 24 hours after receiving thrombolysis
discharge NIHSS score
Time frame: at discharge (up to 30 days)
Rate of patients with any systematic bleeding
Time frame: during hospital stay (up to 30 days)
Rate of patients with 90 days mortality
Time frame: at 90±7 days
Rate of patients with any intracranial hemorrhage
Time frame: during hospital stay (up to 30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Dong principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Dong, M.D. Ph.D. (86-021-52887142, qiang_dong163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with symptomatic intracranial hemorrhage within 36 hours (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.